AB0897 Impact of risankizumab on improving symptoms and health-related quality of life and reducing fatigue and pain among psoriatic arthritis patients with moderate-to-severe skin involvement: Evidence from two Phase III trials
Authors: K. Papp, A. M. Soliman, C. Kaufmann, L. Barcomb, Z. Wang, D. White, A. Ostor, L. E. Kristensen
Journal: Annals of the Rheumatic Diseases (2022)

Background Psoriatic arthritis (PsA) greatly affects patient-reported health-related quality of life (HRQoL). Objectives To assess the impact of risankizumab (RZB) on patient-reported outcomes (PROs) in patients with high skin burden using integrated efficacy data from two Phase III clinical trials (KEEPsAKE-1 and KEEPsAKE-2). Methods Adult patients with PsA with inadequate response or intolerance to disease-modifying antirheumatic drugs were randomized 1:1 to receive RZB (150 mg) or placebo (PBO). Improvement from baseline in PROs (Patient’s Global Assessment of Disease Activity [PtGA] by visual analog scale [VAS], Short-Form 36 Health Questionnaire physical and mental component summary scores [SF-36 PCS and MCS], Health Assessment Questionnaire – Disability Index [HAQ-DI], EQ-5D 5-Level questionnaire [EQ-5D-5L] index and by VAS, Functional Assessment of Chronic Illness Therapy – Fatigue [FACIT-Fatigue], and pain by VAS) were assessed at Week 24 in patients with high skin burden (body surface area involvement ≥3% and Psoriasis Area Severity Index &gt;10). Least squares mean (LSM) difference (95% confidence interval [CI]) between RZB and PBO groups based on mixed-model repeated measures regression is reported. Results RZB- vs PBO-treated patients demonstrated greater improvements in PROs with notable LSM differences (95% CI) between groups ( P &lt;0.01) in PtGA (-18.7 [-25.1, -12.2]), SF-36 PCS (6.3 [4.2, 8.4]) and MCS (4.4 [2.3, 6.6]), HAQ-DI (-0.4 [-0.5, -0.3]), EQ-5D-5L index (0.1 [0.1, 0.2]) and VAS (8.2 [2.5,13.9]), FACIT-Fatigue (4.9 [2.7, 7.2]), and pain (-18.9 [-25.1, -12.7]). Conclusion In patients with PsA with high skin burden, 24 weeks of RZB treatment, as compared with PBO, improved patients’ HRQoL, including fatigue and pain. Acknowledgements AbbVie funded the study and participated in interpretation of data, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing services were provided by Samantha Francis Stuart (Fishawack Facilitate Ltd) and funded by AbbVie. Disclosure of Interests Kim Papp Speakers bureau: AbbVie, Akros, Amgen, Anacor Pharmaceuticals, Arcutis Biotherapeutics, Astellas, Avillion, Bausch Health, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus BioSciences, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo Biosciences, Galapagos NV, Galderma, Gilead, GlaxoSmithKline, Incyte, Janssen, Kyowa-Hakko Kirin, LEO Pharma, MedImmune, Meiji Seika Pharma, Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Genzyme, Sun Pharma, Takeda, UCB, and Xencor., Consultant of: AbbVie, Akros, Amgen, Anacor Pharmaceuticals, Arcutis Biotherapeutics, Astellas, Avillion, Bausch Health, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus BioSciences, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo Biosciences, Galapagos NV, Galderma, Gilead, GlaxoSmithKline, Incyte, Janssen, Kyowa-Hakko Kirin, LEO Pharma, MedImmune, Meiji Seika Pharma, Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Genzyme, Sun Pharma, Takeda, UCB, and Xencor., Grant/research support from: AbbVie, Akros, Amgen, Anacor Pharmaceuticals, Arcutis Biotherapeutics, Astellas, Avillion, Bausch Health, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus BioSciences, Dermavant, Dermira, Dice Pharmaceuticals, Dow Pharma, Eli Lilly, Evelo Biosciences, Galapagos NV, Galderma, Gilead, GlaxoSmithKline, Incyte, Janssen, Kyowa-Hakko Kirin, LEO Pharma, MedImmune, Meiji Seika Pharma, Merck-Serono, Merck Sharp &amp; Dohme, Mitsubishi Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Genzyme, Sun Pharma, Takeda, UCB, and Xencor., Ahmed M. Soliman Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Christian Kaufmann Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Lisa Barcomb Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Zailong Wang Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Douglas White Speakers bureau: AbbVie and Novartis., Consultant of: AbbVie and Novartis., Andrew Ostor Speakers bureau: BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Eli Lilly, and Novartis., Consultant of: BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Eli Lilly, and Novartis., Grant/research support from: BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Eli Lilly, and Novartis., Lars Erik Kristensen Speakers bureau: Pfizer, AbbVie, Amgen, Forward Pharma, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly, and Janssen, Consultant of: Pfizer, AbbVie, Amgen, Forward Pharma, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly, and Janssen, Grant/research support from: UCB, Novartis, Pfizer, Eli Lilly, Biogen, AbbVie, and Janssen Pharmaceuticals and UCB.